Foot orthosis support device method and apparatus

ABSTRACT

A flexible support device adapted to provide overall structural biomechanics support and contouring of a lower limb of a patient by a practitioner where the flexible support device having various indentations to provide proper fitting of a bold for production of an orthosis device in one form.

RELATED APPLICATIONS

This application claims priority benefit of U.S. Ser. No. 11/038,678, filed Jan. 18, 2005, U.S. Ser. No. 60/628,087, filed Nov. 17, 2004; U.S. Ser. No. 60/552,491, filed Mar. 12, 2004; and U.S. Ser. No. 60/537,040, filed Jan. 16, 2004.

BACKGROUND OF THE INVENTION

Orthotics and lower limb orthosis devices, in one form, are made for patients by practitioners for a custom fit to accommodate a patients lower limb support needs. It has been found, in the practice of forming foot orthotics or orthoses, that the logistics of transporting product from the factory to the practitioner is time-consuming, as the practitioner must first send a mold back to the manufacturing facility. Further, there is an issue of maintaining product at the practitioner's location whereby constantly sending molds to the manufacturer can deplete the practitioner's supply of stock mold materials.

Therefore, in one form it is desirable to have an embodiment where a semi-rigid device used to make a negative mold of a patient's foot is not sent back to the orthosis manufacturer, but rather, can be stored at the practitioner's location for reuse. Further, storage space is generally not plentiful at a practitioner's business location, and maintaining inventory of foot molding products can be very challenging. In one form, the embodiments below disclose a convenient method of storing and stacking the flexible members.

The description relates to a flexible support device that is adapted to be used in assisting in the molding casting process. In general, a negative shape of the patient's foot is cast for purposes of creating a dynamic ankle foot orthosis. It should be noted that the foot cast is for the lower leg including the ankle portion, as well as the lower foot region of a patient, essentially the biomechanical structures below the knee of a patient.

Another area of the disclosure relates to pediatric orthotics utilizing a flexible support device. In areas where custom orthotics are not appropriate for various budgetary reasons, a mild support system is advantageous for various young people with foot misalignments. Therefore, pre-made orthotics have provided a service where foot support is appropriate.

During pronation of a foot there are three significant segments of the foot that must be controlled. The heel area during pronation tends to shift into eversion. Eversion is an anatomical condition where the heel, with respect to the ankle, is repositioned and rotates about a longitudinal axis laterally outwardly. The longitudinal arch must maintain a proper biomechanical position and alignment. During pronation the arch moves medially and distally to a flat position, more so in the medial direction. Finally, the forefoot will shift laterally outwardly to abduction. Therefore, all three of these occurrences happen in conjunction and the heel and the arch in the forefoot will shift commensurate with the misalignment of each general foot region.

It should be noted that during collapse of the mid foot longitudinal arch, the skin surface of the heel will remain substantially intact with the weight-bearing surface, but the upper portion of the heel will move laterally inwardly, rotating about a substantially longitudinally extending axis.

Therefore, an effective orthotic or orthosis device must address all three of these simultaneously while providing for movement and general athletic motions of the patient. The device should address these misalignment issues and be comfortable and wearable by the patient.

A further embodiment of the invention is to have an off-the-shelf non-customized device for the patient as well. Further, because patients that are young are growing and outsize these devices in a relatively short amount of time, there is an economic incentive to make a less expensive device which will have a limited lifetime irrespective of the use and wear of the device.

Deep foot orthotics are problematic in that they have not often been comfortable to patients. Therefore, the challenge has been to provide a comfortable off-the-shelf foot orthotic that provides support and adapts to various patients' feet without specific molding.

Pre-made inserts have been problematic because of the instability associated with them.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an upper front isometric view of a flexible support device;

FIG. 2 is an isometric view of a flexible support device showing the various regions of the device;

FIG. 3 shows an assortment of sizes of flexible support devices stacked in a convenient volumetrically efficient fashion;

FIG. 4 shows sizing of a flexible support device with respect to a patient's foot;

FIG. 5 shows a second sock stockinette positioned over the flexible support device and generally around the foot of the patient;

FIG. 6 shows positioning of a member that aids in the prevention of injury when removing a cast;

FIG. 7 shows flexible strips in a flexible state wrapped around the foot of the patient;

FIG. 8 shows the practitioner positioning the ankle region of the patient for proper alignment;

FIG. 9 shows a method of removing the cast from the leg of the patient;

FIG. 10 shows removal of the flexible support device from the cast;

FIG. 11 shows a method of altering the flexible support device to accommodate a patient with a narrow foot;

FIG. 12 shows a method of overlapping the flexible support device to accommodate a narrower foot of a patient;

FIG. 13 shows a method of repositioning the flexible support device by applying heat to a localized area;

FIG. 14 shows alteration of the flexible support device to accommodate a particular patient;

FIG. 15 is an isometric view of a rigid shell device:

FIG. 16 schematically shows another device adapted to measure the lower limb portion of a patient;

FIG. 17 shows a casting device operating in conjunction with an insert adapted to cooperatively function in a manner to get a proper measurement of the foot of a patient;

FIG. 18 shows another modular arrangement of devices adapted to properly measure the lower limb of a patient for purposes of creating an orthotic or orthosis;

FIG. 19 shows an exploded view of an orthotic support device having a soft inner shell and a harder outer shell;

FIG. 20 shows an isometric view of an orthotic support with a soft inner shell having edge portions protruding beyond the edge portions of the outer shell;

FIG. 21 shows a bottom view of an orthotic support device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general, the specification below will first describe one form of casting a lower limb orthotic/orthosis device whereby a flexible support device is employed. Thereafter, with reference to FIGS. 15-18, a second embodiment is shown whereby the second embodiment can be used in various forms to provide the practitioner numerous options for producing an orthotic/orthosis device. In general, the shell as shown in FIG. 15 can be used as a casting device, or alternatively as a measuring device to measure the general contours of a patient's foot where only the measurements need to be sent to a manufacturing facility for production of an orthosis (or simply used to provide a specific size and shape of orthosis premade). Further, the embodiments as shown in FIGS. 15-18 can be used in a modular-type arrangement were modular components are arranged to provide a wide variety and proper fit to the patient. Finally, the embodiments as shown in FIGS. 19-21 show a system where a rigid shell is employed with an interior soft shell, where in this version, the rigid outer shell is essentially the end product that provides support for the patient and the interior soft shell can absorb localized protrusions and indentations for a more comfortable fit for the patient.

As shown in FIG. 1 the flexible support member 20 is shown. As shown in this figure, an axis system is defined where the arrow indicated at 22 indicates a longitudinal axis. Likewise, the orthogonal arrow 24 indicates a lateral axis. Finally, the arrow that is orthogonal to the two mentioned arrows is indicating a vertical axis 26.

As further shown in FIG. 1, the flexible foot support 20 has a medial region generally indicated at 28 and a lateral region generally indicated at 30. Further, the longitudinally forward region is generally referenced as a distal region 32 and the opposed longitudinal region is commonly referred to as a proximal region 34. In addition to the aforementioned regions, a plantar region indicated at 36 defines the general upper surface that comes in contact with the lower portion of a patient's foot. The medial lateral wrap region generally indicated at 38 is a substantially vertical region that is adapted to encompass the calcaneus (a portion of the heel bone), the medial arch which is sometimes referred to as the longitudinal arch, and the navicular. Further, the medial lateral wrap region is adapted to cover the first metatarsal head and the fifth metatarsal head, the base of the fifth metatarsal head and the peroneal arch.

As shown in FIG. 2, the plantar region 36 is approximately defined as the central region within the encompassed section 40. The hatched region around the upper perimeter is substantially defined as the medial lateral wrap region as described above. The plantar region 36 is defined to have various regions as shown in FIG. 2. Beginning in the longitudinally rearward section, the heel depression indicated at 42 is defined as a region adapted to be depressed to a patient's heel during a molding process. The heel depression region 42 provides a foundation for the medial lateral wrap region 38 as described further below and this region of the material is adapted to work in conjunction with this longitudinally rearward portion to correct various skeletal biomechanical misalignments such as pronation, supination, and varus-valgus. The peroneal arch is a region 44 where the surface raises somewhat vertically. The peroneal arch is distal to the heel depression to help control the heel (calcaneus position), and is right behind the base of the fifth metatarsal. This region helps support the arches of the foot and overall foot alignment. It should be noted that the peroneal arch region 44 is a vertical indentation which is represented in the outer surface of the flexible support devices 20. This can be advantageous for providing feedback to a practitioner when casting to denote a certain position. Further, the region 44 is a potential reference point to aid instruction when instructing a practitioner to properly exercise a molding process and aligning the bone structure of a patient described further herein below.

Also shown in FIG. 2, the medial arch region 46 is defined generally as a raised region in the central portion of the plantar region 36. As with the peroneal arch region 44, the medial arch region has a raised region which a practitioner can use to grab when conducting and creating a mold upon a patient as described further herein below. The flexible support member 20 by default has a raised medial arch region. It should be noted that the member is flexible and described further herein below. The medial arch is useful in aligning the avicular navicular and assisting in properly aligning the foot to a solid functional biomechanical neutral position as opposed to a pronated foot or supinated foot. The metatarsal arch indicated at 48 is a raised region adapted to support the metatarsals, particularly the central metatarsals 2, 3 and 4.

Further shown in FIG. 2 is the metatarsal depression generally indicated at 50. This region is defined as a region that supports and aligns the metatarsal heads.

The most forward distal region indicated at 52 is the toe rise region. This region is divided into a drop first toe subregion 54 and a two-five subregion 56. The drop toe subregion 54 is positioned slightly vertically lower with respect to the two-five subregion 56. From the sulcus, the two-five subregion 56 slopes downwardly in the longitudinally forward direction toward the distal area and downwardly to the laterally outward region indicated as 58. This region helps align the foot and allows propreaceptive input for the client so that the foot may be aligned properly. Specifically, the surface allows the client to become aware of his feet and his foot placement. Therefore the raised region brings this awareness to the client during the casting process, allowing for a better mold.

There will now be discussion of the molding process, during which a practitioner will take a mold of the lower foot region of a patient. As shown in FIG. 3, the first step in the molding process is to choose the proper size of a flexible support device. FIG. 3 shows an assortment of sizes of flexible support devices to accommodate a wide variety of patients. As shown in this figure, the variety of flexible support devices 20 are adapted to be stacked as shown. In other words, the cavity region of a larger flexible support device will support the next smaller size. In a storage location, the flexible support devices are arranged in a stacked position whereby an outer surface of an immediately smaller flexible support device is engaged in a cavity region of the immediately larger flexible support device so the plurality of flexible support devices are arranged in a stacked manner. This allows for storage of quite a few flexible support devices in a practitioner's office. Further, this stacking method facilitates in sizing up the proper flexible support member 20 so the practitioner can easily identify which size would be appropriate. For example, if the practitioner chooses one of the central sizes and it is does not properly fit the patient, the practitioner can gauge the difference of size required and skip a set number of increments smaller or larger to gauge the approximate appropriate size for the particular patient.

Thereafter (or prior to sizing), a stockinette is placed on the patient's foot as shown in FIG. 4. A stockinette is defined broadly as a flexible cover to provide some protection and at least partial separation between respective inner and outer portions of the stockinette. In one form the stockinette is made from a fabric-like material, similar to an expandable sock. The foot is then placed into a properly sized flexible support device 20. The various plantar surfaces described above with reference to FIG. 2 must be aligned with the corresponding anatomy of the patient's foot. In particular, the heel region of the patient should be pressed firmly against the substantially vertical surface of the proximal region 34 of the medial lateral wrap region 38. Referring back to FIG. 2, the proximal location of the medial lateral wrap region 38 generally indicated at 39, is referred to as the heel cup region. One advantageous aspect of the heel cup 39 is that it provides an initial foundational support when molding.

When not providing a vertical support region in the heel cup the prior art support members will move with respect to the foot to improper locations. This leads to improper casting and an eventual poor support device. Therefore, having the heel cup region 39 aids in preventing an improper casting.

Now referring to FIG. 5, it can be seen that the heel region 70 of the patient is pressed firmly against the heel cup region 39 of the flexible support devices 20. After the heel is properly aligned in the rearward, proximal location of the flexible support device 20, the practitioner must check the distal regions to ensure that the metatarsal heads are not crossing the total sulcus. Referring back to FIG. 2, the total sulcus indicated at 45 is the distal method proximal toe rise area indicated at the laterally extending line designated by 45. Although other portions of the anatomy could be aligned to the flexible support device, this region is accessible to view by the practitioner and generally, the intermediate plantar surface regions will be properly positioned corresponding to the anatomy of the patient. Referring back to FIG. 4, it is advantageous to have the overall length of the flexible support device slightly longer than the toes 72 of the patient. In other words, this region is not critical for a proper mold and therefore the extra space indicated at 73 between the toes 72 and the forward vertical region 33 will not generally be a problem in molding. In one form, the gap region between the forward surface of the patient's toes 72 and the forward vertical region 33 is approximately a quarter of an inch or greater.

FIG. 5 further shows the application of a second stockinette 74. In one application, a second stockinette is applied over the flexible support device 20 and the initial layer of stockinette. The second layer of stockinette is advantageous for removal of the layer of the cast that is to be applied which is described below. Further, it has a second advantage of aiding the removal of the flexible support device 20 after the mold has at least partially cured and taken a substantially rigid form (also described further below). Further, the second stockinette 74 increases the net volume of the positive mold which represents the foot and ankle region, the first and second stockinettes and the flexible support device 20.

As shown in FIG. 6, a cutting strip 76 that is shown beneath the second stockinette 74 is “wormed in” down a portion of the patient's leg and foot region. In one form, this is located in the forward central region to facilitate a buffer region when removing the mold. This cutting strip is applied underneath one of the two stockinettes. In another form the cutting strip is applied in the outer surface of the stockinette 76. Appling the cutting strip 76 is an optional process for aiding in the removal of the mold if a non-flesh-cutting element is used to remove the mold. It in another version, the cutting strip is taped or otherwise attached to the inner stockinette.

As shown in FIG. 7, pliable molding strips 95 are wrapped around the second stockinette 76 (see FIG. 6) in one form the molding strips are fiberglass, but any substance that is initially pliable and can harden to a mold after a few minutes would suffice. The preset state of the fiberglass rolling is generally a condition where the fiberglass tape is wet and wrapped around the entire ankle foot region with the stockinette applied thereon as shown in FIG. 6. The molding strips 95 are defined broadly to cover all materials that have the ability to be applied in a very flexible form fitting manner and harden to at least a semi-rigid state to preserve a negative mold of the outer surface of the inner structure members (e.g. the contour of the lower limb and the flexible support device). When the molding strips are all applied to the foot region they collectively form a wrap 97 as shown in FIG. 7.

Before the wrap 97 hardens, the practitioner engages in an alignment and feature definition process. This process essentially positions the foot into a proper neutral biomechanical position to form a proper mold. As described above, the features of the flexible support device 20, given its flexibility, allow the practitioner to have a greater amount of control over the manipulation of the position of the various features of the foot and lower limb regions of the patient. In other words, without some flexibility of the flexible support device 20, the anatomical features of the foot would not be manipulated. However, the flexible support device is sufficiently rigid to allow a distribution of pressure upon adjacent regions of the foot and lower ankle region that the practitioner is not in direct contact with. The goal is to have the mold formfitting to the contours of the patient's foot and maintaining the correct overall biomechanical alignment.

The aforementioned arch regions as shown in FIG. 2 assist in aligning the arches to form a proper mold. As shown in FIG. 7, the hindfoot is stabilized with the hand indicated at 90. The thumb is on the navicular bone of the patient and supply a vertical force indicated by arrow 92 helps to define a longitudinal arch. The fingers span the instep region 94 and the forward tip portions of the practitioner's fingers grasp the calcaneus region and in some cases help remove the pronation of the patient. If the patient does not have a pronation problem, the left-hand 90 will support the ankle region so it is properly neutrally aligned. The palm of the hand 90 is on the medial side of the foot and the fingers extend around the back of the heel.

The practitioner's other hand 99 of the practitioner brings the forefoot to the neutral position. A neutral position must be executed about a longitudinal axis so the portion of the foot is properly positioned. Further, the medial and lateral alignment must be properly aligned as well. It is important to keep the heel vertical, therefore there may be some sacrifice in keeping the forefoot horizontal in order to properly align the heel region of the patient's foot. The heel alignment is the base, and given the individual's range of motion, the best biomechanical alignment is obtained. The flexible support device provides a more gradual transition from the forefoot to the rear foot because the rigidity and flexibility of the flexible support device 20 will allow any manipulation to extend longitudinally rearwardly and supply a force along the surface of the foot. In other words, even though the practitioner will exert a force on the distal region of the foot, this force is distributed longitudinally rearwardly to the heel region because of the flexibly controlled deformation of the flexible support device. Without the flexible support device 20, any manipulation by the practitioner's fingers will create a localized depression upon the wrap 97. However, with the flexible support device contained thereunder, any manipulation is not directly applied but it is more uniformly distributed around the adjacent regions were pressure is applied. Given that the flexible support device already has a preset form of key features and depressions as described in FIG. 2, these features are better maintained. The flexible support device provides a more natural transition of manipulation from the rearward portion of the foot to the forward portion of the foot.

As shown in FIG. 8, the process of the alignment and feature definition process is substantially complete and the wrap 97 is beginning to cure to some degree and taking a solidified form. At this point the practitioner has the ability to manipulate localized regions for a better detailed fit. As shown in FIG. 8, the practitioner is contouring the heel to a proper alignment. Of course the practitioner may choose to contour other regions to take a proper neutral biomechanical set form. It should be noted that when pressure is applied the medial lateral wrap region 38 as shown in FIG. 2, the precured wrap 97 disperses pressure and aids in not allowing “flesh displacement”. In other words, particularly in younger patients with more “fleshy” feet that contain greater fat deposits, the medial lateral wrap region 38 allows a more proper distribution of pressure when the wet flexible wrap 97 is applied therearound. The flexible support device 20 having a central chamber region aids in positioning the patient's foot from the beginning of the molding procedure. In other words, instead of having a substantially planar device without sidewalls, the medial lateral wrap region aids in initially positioning the foot so the margin of error is reduced for the alignment of the various arch and depression regions 42-50 discussed in FIG. 2 and the corresponding anatomical portions of the foot. The patient's foot is channeled into this chamber region and there are less manipulation and alignment issues for the practitioner to be concerned with when performing the mold.

As shown in FIG. 9, the cast is removed by incising the front portion with any conventional type of tool. Any particular chosen method of cutting the cast after it has cured can be employed. It should be noted that the flexible support device 20 aids in the removal of the cured cast from the patient's foot because it allows for a distribution of pressure around the lateral regions of the foot during removal. The flexible support device 20 further minimizes distortion during cast removal when the forward central region of the cast must be expanded and pried laterally outwardly to allow the foot and ankle to be interposed and removed therein between the cut portion. Minimizing the deformation of the cast is useful when the cast is not fully cured, which can be a problem when colder water is used when beginning the curing process of the cast, or other reasons that may lead to a slow curing process.

FIG. 10 illustrates one particular use of the flexible support device 20. As shown in this figure, the flexible support device 20 is removed from the cast 80. This allows for reuse of the flexible support device. This removal can be executed by the practitioner and the practitioner can thereafter properly store the flexible support device in the manner as shown in FIG. 4. This is particularly advantageous because in one form of prior art practice, the entire cast is sent to a third-party company which makes the final orthosis support device. This allows the practitioner to refrain from sending support devices adapted to be positioned on the lower portion of the patient's foot to be mailed along with the cast to a third party fabricator. This depletes the supply of support devices for the practitioner, who makes the cast at a location which is generally not the location where the final orthosis support device is created. Therefore with the present invention, the practitioner maintains his supply of the flexible support devices as shown in FIG. 4.

There will now be a discussion of various adjustments that can be made during the molding process with initial reference to FIG. 11. As shown in this figure, the flexible support device 20 is incised in a substantial longitudinal direction. Now referring to FIG. 12, the flexible support device can be overlapped at the region indicated at 91 to provide for a patient's foot that may be narrower in the lateral direction. This provides flexibility for various shapes feet of patients. It should be noted that when a shorter and wider foot is required to be molded, the medial lateral wrap regions 38 have a certain amount of flexibility to allow this wider foot to be contained in the chamber region of the flexible support device 20. The support infrastructure of the various interior surfaces described on FIG. 2 is maintained even when a wider foot is entered in the chamber region of the flexible support device 20.

In the situation where there are bony prominences or extreme shapes of a patient's foot which require special accommodation, reference is made to FIGS. 13 to 16. As shown in FIG. 13, a heating element 100 supplies heat to a specific location of the flexible support device 20. It should be noted that any area of the flexible support device can be heated and manipulated to accommodate any specific situation with a patient. It is often at the discretion of the practitioner to accommodate various extreme anatomical features of the patient, or any disfigurements. Therefore, by way of example, a formation process is shown in FIGS. 13-16. FIG. 13 shows the heating of the medial region where the first prominent method would be slightly extruded on the patient. As shown in FIG. 14, the region 102 is biased laterally outwardly to accommodate this feature of the patient. Of course various methods of alteration are available, such as an alteration to the flexible support member 20, where the base of the fifth metatarsal bone region 106 is heated so the material becomes plastic and formable where the practitioner can manipulate the region outwardly to accommodate an outward extension of the patient's foot in this region.

It should be noted that the flexible support device 20 is particular adapted for external posting. During this process, shim-like devices are positioned either externally of the wrap or in some cases wrapped internally thereunder. The shim-like devices provide a consistent support surface for maintaining the foot position in a certain natural alignment positioned for molding. As described above, the application of pressure of the shim allows for a more consistent natural transition of forefoot to rear foot, given the rigidity of the flexible support device and the flexibility of the device as well. It should further be noted that the various features as shown in FIGS. 1 and 2 provide assurance that the internal arches of the patient's foot are maintained in the manipulation of the patient's foot during the molding process.

The embodiments as shown in FIG. 15 relate to a rigid outer shell device (control module 120) that can be used for casting or only as a measuring device for determining proper orthoses for the lower leg. In general, the full lower shells comprise a support module shown in FIG. 15 having an approximate section that extends up above the ankle. This is made of a flexible material such as plastic in a similar manner as the flexible support device 20 described above and has a central slit region that allows for it to be adjustable. The key features are molded into this module, such as an arch or other anatomical regions as described in shown in FIGS. 1 and 2. Further, prominent features of the foot are compensated for as well.

In one form, the control module 120, which is one form of a flexible support device, can be used to assist in casting whereby modules are placed around the patient's foot and squeeze tight for proper fitting. Thereafter, the practitioner, using standard mold casting techniques that are described above, is able to create a correct negative cast of the patient's foot. Thereafter, this cast is sent to a facility (or executed on site) whereby the control module is a known fixture of a cast and making an improper positive model of the patient's foot can be avoided. Thereafter, there is a positive model (mold) that is used to create an orthosis support device.

It should be noted that it is advantageous to have the lateral lower portion extend over the foot as well as have the proximal section extend up the lower calf of the patient to control foot position during the casting.

A second application is to use the control module as a sizing shell, whereby no casting is conducting by the practitioner, but the particular size of the control module is relayed back to the manufacturer of the final braces to eliminate casting and the physical mailing of the cast which is expensive and causes a time delay.

To facilitate the communication of the proper sizing of the foot without taking a cast, marking indications, such as shown in FIG. 15, can be employed whereby the ridge 130 will engage certain coinciding locations with certain markings 132 which would be indicated by certain measurements. As shown in FIG. 16, this could be accomplished with a strap like system having a base support 140 having a plurality of flexible measuring devices 142.

Another element of the apparatus is to have modular components as shown in FIG. 17. As shown in this figure, there is a rigid foot structure component 150 having a central lower cavity region 152 that is adapted to receive an orthotic-like insert 154. The theory is that the practitioner can fit the shell to the patient and further have the flexibility of fitting one of the stock orthotic molds to the patient as well. The shell can have various lines 156 or other adjustment features to quantify the position and orientation of the orthotic-like insert 154.

As shown in FIG. 18, the modularity can further extend to having a lower semi-rigid fitting module 160 and then an upper semi-rigid module 162. These modules can work in combination and be taken from a plurality of modules that could be stacked in a manner similar to FIG. 3 to properly fit the patient.

This concept can be taken further to having an off-the-shelf type orthotic with mix-and-match components to properly fit the patient.

Now referring to the embodiment shown in FIGS. 19-21, the apparatus 220 comprises an outer support shell 222 and an inner liner 224. In general, this embodiment employs a rigid shell to provide a proper orthosis devise for the patient and further uses an inner soft shell liner to accommodate various bio-structural variations between patient to patient. In general, this embodiment does not employ casting, but rather the plastic shell itself is provided as the end product for the user to wear for lower limb support.

The outer shell has an interior chamber region and the inner liner has an exterior surface that is adapted to engage the inner surface of the outer shell 222. The outer support shell 222 comprises a perimeter support region 226 having medial and lateral sections 228 and 230. The outer support shell 222 further has a heel cup 232 in the rearward portion of the apparatus 220. The perimeter support region 226 is positioned in a location that is an approximate support location for the patient. In other words, the outer shell provides a rigid support to control the biomechanical positioning and alignment of the patient.

The outer support shell is made of a rigid material such as plastic, but does provided a certain amount of flexibility or comfort to account for various foot positions which the patient may be in without allowing the foot to completely collapse.

The embodiment shown in FIGS. 19-21 is adapted to be an off-the-shelf type orthotic utilizing proprioceptive feedback (sensory feedback); this is important in providing the patient with a heightened sense of foot position to aid in proper alignment of his or her feet.

The perimeter region 226 provides a certain amount of flexibility; when it is depressed by hand with a modest grip, the size will deflect inward or outwardly a few millimeters. It is important to note that this flexibility provides functionality for accommodating a wide range of patients' feet. Further, the flexibility allows for a footwear device such as a shoe or a boot to press upon the outer surface of the outer support shell to provide a better and more accommodating fit. The outer support shell 222 has an overall thickness between 0.5 and 3 millimeters in the broader range. A more preferable range is between 1/16 of an inch to 90 thousandths of an inch. In one form, a polyethylene base plastic is used to mold the outer support shell 222. Of course other materials providing flexibility and strength can be employed.

As shown in FIG. 21 the under portion of the outer support shell 222 comprises a variety of support sub region surfaces. It should be noted that this underside of the surface correlates to a raised region on the chamber region of the outer support shell 222. As shown in this figure, the peroneal surface 244 is located on the laterally outward region; the metatarsal raised region 246 is located in the forward medial region and adapted to engage the metatarsals of the patient. The medial longitudinal arch indicated at 248 is adapted to provide the common support in the laterally inward medial region of the patient. These arches are accentuated to some degree to give proprioceptive feedback to the patient so he or she will be induced to mentally align his or her foot to enhance his or her development of voluntary control of foot alignment.

As shown in FIG. 20, the outer support shell 222 has a rearward upper perimeter ridge region 250. This region is positioned vertically below the perimeter ridge 266 of the inner support liner to provide a blending of pressures from the perimeter region 250. In other words, by positioning the perimeter ridge 266 above the lower rigid ridge 250, less direct edge pressure is applied to the foot region of the patient. The inner liner 224 provides the smooth transition to prevent that focused edge pressure that would otherwise be present and create discomfort with the patient. The upper portion of the inner liner allows for an automatic adjustment of the pressure, so the upper perimeter ridge region 250 need not be custom to the patient; rather, the apparatus 220 is self-adjusting to each patient.

The inner liner 224 protects the side of the foot as it shifts positions from the proximal edge of the support shell. In other words, the patient is less likely to engage the perimeter rigid region 250 and have their flesh have a localized pressure developing an irritation.

There will now be a description of the inner liner 224 with initial reference to FIG. 19. As shown in this figure, the inner liner 224 comprises a base region 260 and a forward region 262. The inner liner 224 further has an upper region 264 that comprises a perimeter ridge 266. The construction of this inner liner 224 is generally made from foam. In one form, the inner liner 224 is made from closed-cell 5-pound density foam from ethylene vinyl acetate.

The forward region of the outer support shell 222 has a lateral region 270. As shown in FIG. 20, the inner liner 224 has an extension region 272 that extends longitudinally forward from the lateral region 270. The inner liner 224 is adapted to extend out and cover the metatarsal head. The support shell is adapted to be terminated just prior to the fifth metatarsal head on the lateral side. It should be noted in FIG. 20 that the medial side is adapted to be cut back before the first metatarsal head.

By having the outer support shell 222 provide the rigid structure so the extension region 272 is positioned at substantially right angles from the lateral region to the plantar region, the inner shell provides some rigidity to prevent abduction of the foot when the foot pronates. This is a condition when the medial longitudinal arch of the patient collapses.

Now referring to FIG. 19, the general area indicated at 80 is defined as a pivot region where the metatarsal heads approximately end and, in an operating environment, the patient will pivot when walking or running. It should be noted that the lateral region 270 terminates prior to this pivot region 80 to not interfere with the pivoting action. However, the region 272 of the inner shell 224 being more flexible and made from foam-like material will accommodate the pivoting action during walking or running (or other bipedal motion).

Therefore, it can be appreciated that the apparatus 220 is well suited to prevent pronation of a patient's foot which is a common joint misalignment biomechanical issue in many young patients. The medial section 228 of the perimeter support region 226 will have a tendency to apply a pressure on the medial region to prevent the pronation described above. Further, with the cup region orientated where the rearward surface extends in a plane that is substantially orthogonal to the longitudinal axis and the medial region in a plane orthogonal to the lateral axis, additional support is provided and added rigidity is a benefit to prevent eversion of the heel.

The depth allows the flexible support shell to function properly because having the vertical region indicated at 227 in FIG. 19 allows for a greater moment of inertia when a moment is applied about a lateral axis such as a pressure from the patients foot in the lateral region 270. This is particularly advantageous because less material and structure is required to provide that rigidity, creating a lighter more compact orthotic.

The final component of providing a proper biomechanical alignment for the patient is preventing the forefoot from abducting laterally outwardly with respect to the heel region of the patient. As described above in greater detail the lateral region 270 provides a base region for supporting the portion of the inner liner region 272 to aid in supporting in controlling the abduction. As described above, the flexible foam insert provides flexibility during running where it will actually collapse to a certain degree to provide the range of motion for the patient.

The apparatus 220 is particularly useful in an environment of footwear such as a shoe where the upper perimeter ridge 266 of the inner liner 224 is adapted to position laterally outwardly with respect to the center chamber region of the shoe. In other words, the extension region 272 is easily repositioned and grasped laterally outwardly by the patient and the perimeter region of the patient's foot will easily glide past the outer support shell 222 and be positioned in proper foot position in the shoe. It should further be noted that given the overall length of the apparatus, it will fit properly in a shoe and not be positioned vertically forward with respect to the shoe to prevent movement of the soft liner inner liner 224.

In one form, a layer on the upper surface of the inner liner 224 can be applied to aid in breathability of the apparatus 220. Further, the coefficient of friction between the foot and stocking of the patient can be adjusted to prevent discomfort such as excessive footwear which may cause blisters or the like.

A further modification can be employed where the lower surface of the outer support shell 222 can be filled with some form of material to provide extra support and rigidity. In one form, the aforementioned arch regions can be enhanced and amplified to facilitate the proprioceptive feedback to the patient.

One form of manufacturing the outer support shell 222 is employing common thermal sheet forming techniques such as draping. However, many forms of manufacture can be employed such as injection molding, milling etc.

While the present invention is illustrated by description of several embodiments and while the illustrative embodiments are described in detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications within the scope of the appended claims will readily appear to those sufficed in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general concept. 

1. A corrective device wearable on a portion of a human below a knee of the human including at least a portion of the human's foot and to be positioned inside of a footwear while on the portion of the human, the portion of the human having at least a misalignment, the corrective device comprising: an inner shell having a first rigidity sufficient to prevent abduction of the foot when the foot pronates, the inner shell shaped to accommodate receiving the portion of the human into the inner shell to supportingly couple with the portion of the human; and an outer shell having a second rigidity, the second rigidity being at least as great as the first rigidity, the outer shell shaped to accommodate receiving the inner shell into the outer shell and to supportingly couple with the inner shell to provide in combination with the inner shell a cumulative support greater than provided by either the inner shell or the outer shell by itself and to accommodate positioning into the footwear for coupling with the footwear, the inner shell and the outer shell being sized and shaped such that when the inner shell is coupled with the portion of the human and the outer shell is coupled with the inner shell and positioned in the footwear, at least a sufficient portion of a pressure is distributed by the second rigidity of the outer shell and the first rigidity of the inner shell over a desired area of the portion of the human to provide an amount of correction to the misalignment of the portion of the human, whereby the human can wear the inner shell inside of the outer shell inside of the footwear in comfort while the portion of the pressure is being applied to facilitate correction of the misalignment.
 2. The corrective device of claim 1 wherein the inner shell and the outer shell as coupled provide a preset form of features including a raised arch region and depressions.
 3. The corrective device of claim 2 for the portion of the body having at least a foot region wherein the preset form of features in part compensates for prominent features of the foot.
 4. The corrective device of claim 2 wherein at least a portion of the features in part establishes a neutral biomechanical set form.
 5. The corrective device of claim 1 wherein the inner shell and the outer shell is shaped and sized to accommodate positioning into the footwear as one of the following: a boot and a shoe.
 6. The corrective device of claim 1 for the portion of the human including a foot region and a heel region wherein the outer shell and inner shell are shaped such that the pressure distribution by the outer shell and the inner shell imparts a force on a distal region of the foot region and is distributed longitudinally rearwardly to the heel region.
 7. The corrective device of claim 1 wherein the inner shell has a thickness between 0.0625 inches and 0.09 inches.
 8. The corrective device of claim 1 wherein portions of the inner shell have a thickness of between 0.5 millimeters and 3 millimeters and wherein portions of the outer shell have a thickness of between 0.5 millimeters and 3 millimeters.
 9. The corrective device of claim 1 wherein the inner shell and the outer shell in combination provide a perimeter region to provide sufficient flexibility to deflect inward or outward by more than a millimeter.
 10. The corrective device of claim 1 wherein the outer shell and the inner shell are couplable to form a lower semi-rigid fitting module and an upper semi-rigid fitting module.
 11. The corrective device of claim 1 wherein the inner shell and the outer shell are made from a polyethylene base plastic, the inner shell being integrally formed as a single first unit and the outer shell being integrally formed as a single second unit.
 12. The corrective device of claim 1 wherein the outer shell has a rearward upper perimeter ridge region and the inner shell has a lower perimeter ridge region, the outer shell and the inner shell are couplable to position the rearward upper perimeter ridge region above the lower perimeter ridge region to lessen edge pressure applied to the portion of a human.
 13. The corrective device of claim 1 wherein the inner shell and the outer shell are couplable to include raised regions located to engage a planter surface of the foot when the foot is positioned within the inner shell to provide sensory feedback to the portion of the human.
 14. The corrective device of claim 1 wherein the outer shell is shaped and sized to receive the inner shell as an orthotic-like insert.
 15. The corrective device of claim 1 for the portion of the human including a foot portion in which the inner shell and outer shell are shaped to provide orthotic sensory feedback to provide the human with a heightened sense of foot portion position to aid in proper alignment of the foot portion to contribute to the correction of the misalignment.
 16. The corrective device of claim 1 wherein the first rigidity and the second rigidity are selected to provide sufficient flexibility of the inner shell and the outer shell to allow prolonged wear by the human.
 17. The corrective device of claim 1 for the portion of the human including a foot portion wherein the inner shell and the outer shell is sized and shaped to allow for the sufficient portion of the pressure to be distributed without allowing the foot portion to completely collapse.
 18. The corrective device of claim 1 wherein the outer shell includes a heel cup region in a rearward portion of the support shell extending upward from below a heel of the foot to at least an Achilles tendon of the foot when the foot is positioned within the inner shell and therealong being in supporting contact with the inner shell, the inner shell including a portion to fully cover the heel and the Achilles tendon of the foot and in supporting contact with the heel cup region of the outer shell when the foot is positioned within the inner shell.
 19. The corrective device of claim 1 wherein the inner shell is couplable into the outer shell to accommodate bio-structural variations of the portion of the human for the outer shell.
 20. The corrective device of claim 1 wherein the outer shell has a central slit region and the inner shell has a central slit region.
 21. The corrective device of claim 1 wherein the outer shell and the inner shell are at least in part plastic.
 22. The corrective device of claim 1 to be worn on the portion of a human including a heel region, wherein the inner shell and the outer shell are sized and shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to align the heel region into a substantially vertical position.
 23. The corrective device of claim 22 wherein the inner shell and the outer shell are sized and shaped such that alignment of the heel alignment is usable as a base for further correction of the misalignment.
 24. The corrective device of claim 1 wherein the inner shell and the outer shell are shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to maintain medial and lateral alignment of the portion of the human.
 25. The corrective device of claim 1 to be worn on the portion of a human including a forefoot region, wherein the inner shell and the outer shell are shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to align the forefoot region into a neutral position.
 26. The corrective device of claim 1 wherein the first rigidity and the second rigidity are sufficiently rigid to distribute a portion of the pressure upon regions adjacent to the misalignment.
 27. The corrective device of claim 1 wherein the outer shell includes a perimeter support region having medial and lateral sections.
 28. The corrective device of claim 1 wherein the outer shell has an interior chamber region with an inner surface and the inner shell has an exterior surface configured to engage with the inner surface.
 29. The corrective device of claim 1 to be worn on the portion of a human including a heel region, wherein the inner shell and the outer shell are shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to align the heel in a rearward proximal location of the corrective device.
 30. The corrective device of claim 1 wherein the outer shell has a lateral region and the inner shell an extension region that extends longitudinally forward from the lateral region of the outer shell.
 31. The corrective device of claim 1 wherein the outer shell has a lateral region with a base region and the inner shell has an extension region, the base region configured to support the extension region to prevent abduction of the foot when the foot pronates.
 32. The corrective device of claim 1 wherein the inner shell has an extension region and the first rigidity of the inner shell is sufficiently flexible when combined with the second rigidity of the outer shell to accommodate a pivoting action of the inner shell.
 33. The corrective device of claim 1 wherein the outer shell has a lateral region and a pivot region, the lateral region terminating before the pivot region.
 34. The corrective device of claim 1 wherein the outer shell and the inner shell in combination provide a base region, a forward region, and an upper region that includes a perimeter ridge.
 35. The corrective device of claim 1 to be worn on the portion of a human including a foot region, wherein the inner shell and the outer shell are shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to align the foot region into a biomechanical neutral position.
 36. The corrective device of claim 1 wherein the inner shell and the outer shell in combination provide a raised medial arch region.
 37. The corrective device of claim 1 wherein the outer shell includes modular components.
 38. The corrective device of claim 1 for the portion of the human having at least the misalignment as at least one of a pronation, a supination, and a varus-vulgus condition, wherein the inner shell and the outer shell are shaped to distribute the pressure for correcting the misalignment.
 39. The corrective device of claim 1 for the portion of the human having at least the misalignment as at least a pronation condition involving at least one of eversion, arch movement to flat position, and abduction, wherein the inner shell and the outer shell are shaped to distribute the pressure for correcting the pronation.
 40. The corrective device of claim 1 to be worn on the portion of a human including an ankle portion and a lower foot region, wherein the inner shell is shaped to accommodate receiving at least a portion of the ankle and the lower foot region into the inner shell.
 41. The corrective device of claim 1 wherein the outer shell has a rearward lower region including a heel cup and a rearward upper region extending upward above the rearward lower region, the rearward lower and upper regions being integrally formed as a unit with sufficient rigidity so as to be non-adjustable and to inhibit rearward rotation of the rearward upper region relative to the lower region.
 42. A method for use with a portion of a human below a knee of the human, the portion of the human having at least a misalignment, the method comprising: providing an inner shell having a first rigidity sufficient to prevent abduction of the foot when the foot pronates; providing an outer shell having a second rigidity at least as great as the first rigidity; receiving the portion of the human into the inner shell to supportingly couple with the portion of the human; and receiving the inner shell into the outer shell to supportingly couple with the inner shell to provide in combination with the inner shell a cumulative support greater than provided by either the inner shell or the outer shell by itself; positioning the outer shell into a footwear while the outer shell is coupled with the inner shell and the inner shell is coupled with the portion of the human; and distributing a pressure by the second rigidity of the outer shell and the first rigidity of the inner shell over a desired area of the portion of the human sufficient to provide an amount of correction to the misalignment of the portion of the human while the human wears the inner shell inside of the outer shell inside of the footwear.
 43. A corrective device for a portion of a human below a knee of the human including at least a portion of the human's foot, the portion of the human having at least a misalignment, the corrective device comprising: first means for receiving the portion of the human to couple with the portion of the human, the first means having a first rigidity sufficient to prevent abduction of the foot when the foot pronates; and second means for receiving the first means for receiving, the second means for receiving including a means for coupling with a footwear, the second means having a second rigidity at least as great as the first rigidity, the first and second rigidities of the first and second means being sufficient to provide in combination a cumulative support greater than provided by either the first means or the second means by itself; and means for distributing a pressure by the first means and the second means over a desired area of the portion of the human sufficient to provide an amount of correction to the misalignment of the portion of the human.
 44. A corrective device wearable on a portion of a human below a knee of the human including at least a portion of the human's foot with a heel and Achilles tendon and to be positioned inside of a footwear while on the portion of the human, the portion of the human having at least a misalignment, the corrective device comprising: an inner shell having a first rigidity sufficient to prevent abduction of the foot when the foot pronates, the inner shell shaped to accommodate receiving the portion of the human into the inner shell to supportingly couple with the portion of the human, the inner shell having a rearward region including left and right side portions and a heel cup extending between and connected to the left and right side portions to fully cover the heel and Achilles tendon of the foot in supporting contact with the foot when the foot is positioned within the inner shell, the left and right side portions and the heel cup being integrally formed as a unit with sufficient rigidity to hold the heel of the foot in a selected alignment against inverting or everting; and an outer shell having a second rigidity, the second rigidity being at least as great as the first rigidity, the outer shell shaped to accommodate receiving the inner shell into the outer shell to supportingly couple with the inner shell to provide in combination with the inner shell a cumulative support greater than provided by either the inner shell or the outer shell by itself and to accommodate positioning into the footwear for coupling with the footwear, the inner shell and the outer shell being sized and shaped such that when the inner shell is coupled with the portion of the human and the outer shell is coupled with the inner shell and positioned in the footwear, at least a sufficient portion of a pressure is distributed by the second rigidity of the outer shell and the first rigidity of the inner shell over a desired area of the portion of the human to provide an amount of correction to the misalignment of the portion of the human, whereby the human can wear the inner shell inside of the outer shell inside of the footwear in comfort while the portion of the pressure is being applied to facilitate correction of the misalignment.
 45. A corrective device wearable on a portion of a human below a knee of the human including at least a portion of the human's foot with an instep and positionable inside of a footwear while on the portion of the human, the portion of the human having at least a misalignment, the corrective device comprising: an inner shell having a first rigidity sufficient to prevent abduction of the foot when the foot pronates, the inner shell shaped to accommodate receiving the portion of the human into the inner shell to supportingly couple with the portion of the human, the inner shell having a middle region including left and right side portions and left and right side extension portions connected to the left and right side portions, respectively, the left side extension portion extending inwardly over and in supporting contact with a left side portion of the instep of the foot when the foot is positioned within the inner shell and the right side extension portion extending inwardly over and in supporting contact with a right side portion of the instep of the foot when the foot is positioned within the inner shell, the left side portion and the left side extension portion being integrally formed as a unit and the right side portion and the right side extension portion being integrally formed as a unit, the left and right side extension portions being disconnected from each other; and an outer shell having a second rigidity, the second rigidity being at least as great as the first rigidity, the outer shell shaped to accommodate receiving the inner shell into the outer shell to supportingly couple with the inner shell to provide in combination with the inner shell a cumulative support greater than provided by either the inner shell or the outer shell by itself and to accommodate positioning into the footwear for coupling with the footwear, the inner shell and the outer shell being sized and shaped such that when the inner shell is coupled with the portion of the human and the outer shell is coupled with the inner shell and positioned in the footwear, at least a sufficient portion of a pressure is distributed by the second rigidity of the outer shell and the first rigidity of the inner shell over a desired area of the portion of the human to provide an amount of correction to the misalignment of the portion of the human, whereby the human can wear the inner shell inside of the outer shell inside of the footwear in comfort while the portion of the pressure is being applied to facilitate correction of the misalignment.
 46. A corrective device wearable on a portion of a human below a knee of the human including at least a portion of the human's foot with a heel, Achilles tendon and instep, and positionable inside of a footwear while on the portion of the human, the portion of the human having at least a misalignment, the corrective device comprising: an inner shell having a first rigidity sufficient to prevent abduction of the foot when the foot pronates, the inner shell shaped to accommodate receiving the portion of the human into the inner shell to supportingly couple with the portion of the human, the inner shell having a rearward region including left and right side portions and a heel cup extending between and connected to the left and right side portions to fully cover the heel and Achilles tendon of the foot in supporting contact with the foot when the foot is positioned within the inner shell, the left and right side portions and the heel cup being integrally formed as a unit with sufficient rigidity to hold the heel of the foot in a selected alignment against inverting or everting, the inner shell having a middle region including left and right side portions and left and right side extension portions connected to the left and right side portions, respectively, the left side extension portion extending inwardly over and in supporting contact with a left side portion of the instep of the foot when the foot is positioned within the inner shell and the right side extension portion extending inwardly over and in supporting contact with a right side portion of the instep of the foot when the foot is positioned within the inner shell, the left side portion and the left side extension portion being integrally formed as a unit and the right side portion and the right side extension portion being integrally formed as a unit, the left and right side extension portions being disconnected from each other; and an outer shell having a second rigidity, the second rigidity being at least as great as the first rigidity, the outer shell shaped to accommodate receiving the inner shell into the outer shell to supportingly couple with the inner shell to provide in combination with the inner shell a cumulative support greater than provided by either the inner shell or the outer shell by itself and to accommodate positioning into the footwear for coupling with the footwear, the inner shell and the outer shell being sized and shaped such that when the inner shell is coupled with the portion of the human and the outer shell is coupled with the inner shell and positioned in the footwear, at least a sufficient portion of a pressure is distributed by the second rigidity of the outer shell and the first rigidity of the inner shell over a desired area of the portion of the human to provide an amount of correction to the misalignment of the portion of the human, whereby the human can wear the inner shell inside of the outer shell inside of the footwear in comfort while the portion of the pressure is being applied to facilitate correction of the misalignment.
 47. The corrective device of claim 46 wherein the outer shell has a rearward upper perimeter ridge region and the inner shell has a lower perimeter ridge region, the outer shell and the inner shell are couplable to position the rearward upper perimeter ridge region above the lower perimeter ridge region to lessen edge pressure applied to the portion of a human.
 48. The corrective device of claim 46 wherein the inner shell and the outer shell are couplable to include raised regions located to engage a planter surface of the foot when the foot is positioned within the inner shell to provide sensory feedback to the portion of the human.
 49. The corrective device of claim 46 for the portion of the human including a foot portion in which the inner shell and outer shell are shaped to provide orthotic sensory feedback to provide the human with a heightened sense of foot portion position to aid in proper alignment of the foot portion to contribute to the correction of the misalignment.
 50. The corrective device of claim 46 wherein the outer shell includes a heel cup region in a rearward portion of the outer shell extending upward to at least an Achilles tendon of the foot when the foot is positioned within the inner shell and the inner shell includes a portion to engage with the heel cup region.
 51. The corrective device of claim 46, wherein the inner shell and the outer shell are sized and shaped such that the amount of correction to the misalignment by the pressure distributed by the second rigidity of the outer shell and the first rigidity of the inner shell is sufficient to align the heel into a substantially vertical position.
 52. The corrective device of claim 46 wherein the outer shell has a lateral region with a base region and the inner shell has an extension region, the base region configured to support the extension region to prevent abduction of the foot when the foot pronates. 